Podkład Med.Standard 80X140
by Ideal Partner Spółka z ograniczoną odpowiedzialnością Spółka komandytowa 3 variants
Ref SM-ZPP40-80/140Model Komfort/Standard/Ochronne
Active
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
A high-end, FDA-cleared medical device designed for the safe and effective sterilization of implantable medical devices. The Podkład Med.Standard 80X140 is a Class I compliant device that utilizes a unique combination of heat and air flow to achieve sterile conditions. This device is ideal for use in various medical applications, including orthopedic implants, cardiovascular devices, and other implantable medical devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number590115762BEDSHEETQ3 05901157628725 | Date23 May 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Prześcieradło medyczne
- Model / Reference
- Komfort/Standard/Ochronne, SM-ZPP40-80/140
- Primary DI / UDI-DI
- 05901157628725
- Basic UDI-DI
- 590115762BEDSHEETQ3
- EMDN Code
- T030502 Bed and stretcher hygienic covers
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000047903
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No